Immediate corticosteroids with rituximab as needed to stop ocular myasthenia from spreading

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, randomized Phase 3 trial comparing immediate corticosteroid therapy (with rituximab added for recurrence) to usual care in adults with ocular-onset myasthenia gravis diagnosed within the past six months. Participants must have eye-limited symptoms for at least one month and be naïve to immunosuppressive therapy. The trial uses a PROBE design across several French university hospitals to measure whether early intervention reduces later generalization to bulbar, axial, or limb muscles. Follow-up focuses on the rate and timing of generalization during the early years when the autoimmune response typically matures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients over 18 years of age
* Diagnosis of ocular myasthenia within the last 6 months, defined :

  * either by a typical clinical examination objectified by an expert clinician: ptosis and/or binocular diplopia, with a variable and fluctuating character (either spontaneous or provoked by effort or rest)
  * or by positive anti-AChR antibodies or the presence of decrement on repetitive nerve stimulation or a positive edrophonium test
* Ocular symptoms lasting at least one month and limited to extra-ocular muscles (weakness in one or both orbicularis oculi)
* No non-ocular symptoms on MMS, MGC and MG-ADL.
* Naïve to immunosuppressive therapy for ocular myasthenia gravis.

Exclusion Criteria:

* Thymoma
* Pupillary anomaly other than that resulting from previous local disease or surgery.
* Signs of restrictive abduction or supraduction myopathy due to dysthyroid ophthalmopathy.
* Graves' ophthalmopathy
* Onset of ocular symptoms more than one year before screening date
* Hypersensitivity to rituximab, murine proteins, prednisone, methylprednisone, aziathioprine or 6-mercaptopurine, paracetamol, dexchlorpheniramine.
* Any infectious condition
* Patients with severe immune deficiency
* Severe heart failure (New York Heart Association (NYHA) Class IV) or severe uncontrolled heart disease
* Severe hepatic insufficiency
* Psychotic states not yet controlled by treatment
* Hyperuricemia on xanthine oxidase inhibitors (allopurinol and febuxostat)
* Risk of angle-closure glaucoma
* Risk of urinary retention due to urethro-prostatic disorders
* Vaccination with live attenuated vaccine required during study and up to 6 months after rituximab discontinuation
* Women of childbearing age who do not wish to use effective contraception during their participation and at least 12 months after
* Pregnant or breast-feeding women

Where it's running

• Centre Hospitalier Universitaire De Bordeaux
  Bordeaux, France Recruiting
• Centre Hospitalier Universitaire De Lille
  Lille, France Recruiting
• Hospices Civils De Lyon
  Lyon, France Recruiting
• Centre Hospitalier Universitaire De Nice
  Nice, France Recruiting
• Fondation Adolphe de Rothschild
  Paris, France Recruiting
• Les Hopitaux Universitaires De Strasbourg
  Strasbourg, France Recruiting

Study contacts

• Study coordinator: Antoine Gueguen
• Email: agueguen@for.paris
• Phone: +33148036852

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.